EPIFOAM 100 mg/10g
pramoxine hydrochloride and hydrocortisone acetate · AEROSOL, FOAM · Viatris Specialty LLC
EPIFOAM is a aerosol, foam containing pramoxine hydrochloride and hydrocortisone acetate at 100 mg/10g, taken topical. Manufactured by Viatris Specialty LLC.
Key Facts
- Brand Name
- EPIFOAM
- Generic Name
- pramoxine hydrochloride and hydrocortisone acetate
- NDC Code (Product)
0037-6824- Manufacturer
- Viatris Specialty LLC
- Strength
- 100 mg/10g
- Dosage Form
- AEROSOL, FOAM
- Route
- TOPICAL
- Marketing Status
- Application #
- ANDA086457
- Marketing Start
- 08/25/2014
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
Dosage & Administration
DOSAGE AND ADMINISTRATION Apply to affected area 3 to 4 times daily. Occlusive dressings may be used for the management of psoriasis or recalcitrant conditions. If an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy instituted. Directions For Use: 1. Shake the container vigorously for 5-10 seconds before each use. 2. While holding container upright, prime the container by pressing down several times on container cap until foam appears. Apply a small amount directly to affected area 3-4 times daily depending on severity of the condition. Alternatively, dispense a small amount to a pad and apply to affected areas. NOTE: The aerosol container should never be inserted into vagina or anus. 3. The container and cap should be disassembled and rinsed with warm water after use.
Warnings
WARNINGS Not for prolonged use. If redness, pain, irritation or swelling persists, discontinue use and consult a physician. Contents of the container are under pressure. Do not burn or puncture the aerosol container. Do not store at temperatures above 120°F (49°C). Keep this and all medicines out of the reach of children.
Contraindications
CONTRAINDICATIONS Topical corticosteroid products are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.
Adverse Reactions
ADVERSE REACTIONS To report SUSPECTED ADVERSE REACTIONS, contact Meda Pharmaceuticals Inc. at 1-877-848-6610 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. The following local adverse reactions are reported infrequently with topical corticosteroids, but may occur more frequently with the use of occlusive dressings. These reactions are listed in an approximately decreasing order of occurrence: Burning, Itching, Irritation, Dryness, Folliculitis, Hypertrichosis, Acneiform eruptions, Hypopigmentation, Perioral dermatitis, Allergic contact dermatitis, Maceration of the skin, Secondary infection, Skin atrophy, Striae, Miliaria
Frequently Asked Questions
What is EPIFOAM used for?
EPIFOAM contains pramoxine hydrochloride and hydrocortisone acetate. It is a aerosol, foam taken topical. Consult your doctor for specific uses.
Is EPIFOAM a controlled substance?
EPIFOAM is not classified as a controlled substance by the DEA.
What is the generic name for EPIFOAM?
The generic name for EPIFOAM is pramoxine hydrochloride and hydrocortisone acetate. There are 1 other brand versions of pramoxine hydrochloride and hydrocortisone acetate.
What is the NDC code for EPIFOAM 100 mg/10g?
The NDC (National Drug Code) for EPIFOAM 100 mg/10g is 0037-6824, listed by Viatris Specialty LLC.